Teva Branded Pharmaceutical Products, R&D, Inc., Frazer, PA, USA.
Published: April 2014
AI Article Synopsis
Article Abstract
Objective: To evaluate the efficacy and safety of an ascending-dose, extended-regimen (ADER) combined oral contraceptive consisting of levonorgestrel (LNG) 150 mcg/ethinyl estradiol (EE) 20 mcg for 42 days, LNG 150 mcg/EE 25 mcg for 21 days, LNG 150 mcg/EE 30 mcg for 21 days and EE 10 mcg for 7 days.
Study Design: This was a multicenter, open-label, phase 3, single-arm study. Sexually active women aged 18-40 years were enrolled and received ADER for up to 1 year (4 consecutive 91-day cycles). Participants kept diaries to record adherence, bleeding/spotting and other contraceptive use. Efficacy was measured using the Pearl Index and the life-table method; safety and tolerability were assessed through reported adverse events (AEs).
Results: A total of 3701 women were enrolled and 2144 completed the study. The Pearl Index was 3.19 [95% confidence interval (CI), 2.49-4.03], based on 70 pregnancies that occurred after ADER initiation and ≤ 7 days after the last LNG/EE or EE-only pill in women aged 18-35 years, excluding cycles in which another contraceptive method was used. Life-table pregnancy rate was 2.82% (95% CI, 2.23%-3.57%) for all users aged 18-35 years. Unscheduled bleeding/spotting decreased with increasing EE doses within each cycle and decreased after cycle 1. No unexpected AEs or changes in laboratory parameters were reported.
Conclusion: This study demonstrated that ADER effectively prevented pregnancy with a favorable safety and tolerability profile.
Introduction: Cariprazine (CAR) is a potent dopamine receptor partial agonist antipsychotic approved by the EMA and the FDA. To address the uncertainty regarding the effectiveness of hormonal contraceptives during CAR co-administration and whether a second barrier method is necessary, a drug-drug interaction study with an oral contraceptive was conducted post-approval.
Methods: The phase I, fixed-sequence multicenter study involved two periods with 24 patients with schizophrenia, aiming to evaluate the effect of CAR on the pharmacokinetics (PK) of a combined oral contraceptive (COC) containing 30 μg ethinylestradiol (EE) and 150 μg levonorgestrel (LNG).
Purpose: The Kyleena™ Satisfaction Study (KYSS) provided the first data on 19.5 mg levonorgestrel-releasing intrauterine system (LNG-IUS-19.5 mg) use in routine clinical practice.
Department of Animal Nutrition and Production, School of Veterinary Medicine and Animal Science, University of São Paulo, Pirassununga, São Paulo, 13635-900, Brazil.
Using on-farm microbiological culture (OFC), based on chromogenic culture media, enables the identification of mastitis causing pathogens in about 24 h, allows rapid decision making on selective treatment and control management measures of cows with clinical mastitis (CM). However, accurate interpretation of OFC results requires trained and experienced operators, which could be a limitation for the use of OFC in dairy farms. Our hypothesis was that AI-based automated plate reading mobile application can analyze images of microorganisms' colonies in chromogenic culture media with similar diagnostic performance as a trained specialist evaluator.
Background: An estimated 25,000 pregnancies result from sexual assault in the United States annually. Numerous professional healthcare organizations endorse offering emergency contraception (EC) as an integrated aspect of post-sexual-assault care. Lack of knowledge surrounding EC's mechanism of action, including misinterpreting ECs as abortifacients, might restrict patient access to this important healthcare option.
